SA Guide to Good Manufacturing Practice for Medicines

This document guides the requirements for Good Manufacturing Practice (GMP) in South Africa.  This guideline is not intended as an exclusive approach.  The South African Health Products Regulatory Authority (SAHPRA) reserves the right to request any additional information to establish the safety, quality, and efficacy of a medicine. SAHPRA may make amendments in keeping with the knowledge that is current at the time of consideration of data accompanying applications for registration of medicines. Alternative approaches may be used, but these must be scientifically and technically justified. SAHPRA is committed to ensuring that all medicines gaining market approval will be of the required quality, safety, and efficacy standards.